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FDA's Medical Device Software Regulation Strategy

 
  September 27, 2020  
     
 
Compliance online, Online Event
November 19-20, 2020


The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated.

  • How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump?
  • Can one software program defeat the performance capability or back up safety features of another software program?
  • When interoperability surface, which software manufacturer takes the lead to solve the problem and deal with proprietary software issues?

This seminar will focus on addressing these concerns and educating participants on FDA’s recent medical device software regulation strategies.

 
 
Organized by: ComplianceOnline
Invited Speakers:
Casper (Cap) Uldriks

Casper (Cap) Uldriks
Former Associate Center Director of FDA's CDRH

Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.

 
Deadline for Abstracts: November 13
 
Registration: https://www.complianceonline.com/fda-medical-device-software-regulation-strategy-seminar-training-by-ex-fda-official-seminar-training-80242SEM-prdsm?channel=hum-molgen
E-mail: referral@complianceonline.com
 
 
   
 
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